MAUDE Adverse Event Report: ROCHE DIAGNOSTICS SAFE-T-PRO; LANCET

Model Number SAFE-T-PRO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

The customer's lancets were requested for return, but the customer used all of the lancets.The investigation is ongoing.

Event Description

The initial reporter stated she had an infection in her finger and hand from a safe-t-pro device and she received medical treatment.The customer stated, "she has stuck the same finger for every test for the last 20 years." the customer stated "the finger was not healing" and her husband drove her to the hospital.The customer was not admitted to the hospital, but she received an iv drip for two hours and then was discharged.

Manufacturer Narrative

Updated medwatch field b2.

Manufacturer Narrative

As no customer product could be returned and the affected lot number could not be provided, further investigation was not possible.No similar customer allegation against the roche product accu-chek safe-t-pro plus has been received.All product batches are controlled with regard to the quality requirements of the product prior to delivery.If all quality requirements are fulfilled in the quality control process, goods are released and ready for delivery.All non-conforming products are handled based on established procedures.Based on the available information, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: SAFE-T-PRO
• Type of Device: LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10802357
• MDR Text Key: 215144441
• Report Number: 1823260-2020-02794
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SAFE-T-PRO
• Device Catalogue Number: 03136752001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization